JOVYNEX WOMEN ESTRIOL- micronized estriol 0.1% women estriol cream

JOVYNEX WOMEN ESTRIOL by

Drug Labeling and Warnings

JOVYNEX WOMEN ESTRIOL by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Micronized Estriol 0.1%

Purpose

Relieves Vaginal Dryness

Use

·Provides temporary relief from intimate dryness and discomfort.·Moisturizes and soothes the intimate area.

Warnings

1.For lntimate use only,not for oral use.

2.The product should not be used as a substitute for medicines and medical devices.

Do not use

Do not use if you are pregnant,during menstruation, or breastfeeding.

When Using

lf this is the first time you are experiencing vaginal dryness or discomfort. consult your healthcare provider.

Stop Use

·you experience abdominal pain.fever, chills,nausea.vomiting of foul-smelling discharge.·symptoms worsen or do not
improve within 7 days.

Ask Doctor

·you experience abdominal pain.fever, chills,nausea.vomiting of foul-smelling discharge.·symptoms worsen or do not
improve within 7 days.

Keep Oot Of Reach Of Children

.Keep out of reach of children,This product is for adult use onlv.

Directions

.Dispense 2 pumps of cream onto clean fingers. ·Smooth over the inner lips and perineum.(Not for internal use). ·Apply once or twice a day：apply at bedtime while lying down. ·Wait 20 minutes for the cream to deeply absorb for maximum overnight benefit.

Other information

Store in a dry and cool place at 20°C-25°C(68°F-77°F).

Inactive ingredients

Purified Water, Vegetable Glycerin, Aloe Vera Gel, Caprylic/Capric Triglyceride,Stearic Acid, Olive Oil, Coconut Oil, Shea Butter, Sunflower Lecithin,MethylsulfonyImethane(MSM), Stearyl Alcohol, Isopropyl Palmitate, Allantoin,Carbomer, Sodium Bicarbonate。

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JOVYNEX WOMEN ESTRIOL 
micronized estriol 0.1% women estriol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E)	ESTRIOL	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CARBOMER (UNII: 0A5MM307FC)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALLANTOIN (UNII: 344S277G0Z)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-237-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2025
2	NDC: 84010-237-02	50 g in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2025
3	NDC: 84010-237-03	100 g in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/22/2025

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-237)